Data from a phase 3 trial investigating Lilly’s severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) neutralizing antibodies, bamlanivimab (LY-CoV555) plus etesevimab (LY-CoV016), showed that the combination significantly reduced hospitalizations and deaths among high-risk patients recently diagnosed with coronavirus disease 2019 (COVID-19).
In the BLAZE-1 study, patients with mild to moderate COVID-19 illness were randomized to receive 2800mg of each antibody or placebo. Findings from the phase 3 portion of the study showed the combination therapy reduced the risk of hospitalization or death (known as an “event”) by 70% (P =.0004); among 1035 patients, there were 11 events (2.1%) in the bamlanivimab plus etesevimab group and 36 events (7.0%) in the placebo group.
“While the preliminary nature of phase 2 results from COVID-19 neutralizing monoclonal antibodies may have limited acceptance of treatment, these phase 3 data further strengthen the available evidence,” said Daniel Skovronsky, MD, PhD, Lilly’s chief scientific officer and president of Lilly Research Laboratories. “Notably, the 70% decrease in risk of hospitalizations or death seen in this phase 3 trial of bamlanivimab and etesevimab together is consistent with the reduction in risk of hospitalization or ER visits seen with bamlanivimab alone in the phase 2 trial.
Results also showed that treatment with bamlanivimab plus etesevimab led to statistically significant improvements in all key secondary end points (ie, reducing viral load, accelerating symptoms resolution).
“These data further support our belief that bamlanivimab and etesevimab together have the potential to be an important treatment that significantly reduces hospitalizations and death in high-risk COVID-19 patients,” added Skovronsky.
Lilly also announced early results from the ongoing BLAZE-4 trial, which demonstrated that lower doses of bamlanivimab and etesevimab (700mg and 1400mg, respectively) were similar to the 2800mg doses based on viral load and pharmacodynamic/pharmacokinetic data. In an effort to maximize supply, the Company will explore even lower doses and is also looking into subcutaneous dosing to reduce the burden on health care systems and patients.
The combination of bamlanivimab and etesevimab for the treatment of mild to moderate COVID-19 is currently being reviewed by the Food and Drug Administration for Emergency Use Authorization (EUA). In November 2020, the FDA issued an EUA for bamlanivimab monotherapy for the treatment of COVID-19.
New data show treatment with Lilly’s neutralizing antibodies bamlanivimab (LY-CoV555) and etesevimab (LY-CoV016) together reduced risk of COVID-19 hospitalizations and death by 70 percent. [press release]. Indianapolis, IN: Eli Lilly; January 26, 2021.